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ARS Pharmaceuticals, Inc. - SPRY STOCK NEWS

Welcome to our dedicated page for ARS Pharmaceuticals news (Ticker: SPRY), a resource for investors and traders seeking the latest updates and insights on ARS Pharmaceuticals stock.

ARS Pharmaceuticals, Inc. (Nasdaq: SPRY) is a pioneering biopharmaceutical company dedicated to developing innovative solutions for patients at risk of severe allergic reactions, potentially leading to anaphylaxis. The company is primarily focused on its flagship product candidate, neffy, a nasal spray formulation of epinephrine designed for emergency treatment of Type I allergic reactions.

ARS Pharma is committed to addressing the limitations of traditional epinephrine autoinjectors, such as needle phobia, portability issues, and complexity of use. neffy aims to provide a needle-free, easy-to-use, and reliable alternative, enhancing patient compliance and timely administration in emergency situations. Leveraging a proprietary absorption enhancer, Intravail, neffy ensures rapid and effective epinephrine absorption comparable to injections.

As of November 2023, ARS Pharma announced that despite initial regulatory hurdles, the company is on track to resubmit its New Drug Application (NDA) for neffy to the FDA by mid-2024, with potential U.S. market launch in the latter half of the year. This follows the FDA's additional requirement for a pre-approval repeat-dose rhinitis study, which ARS Pharma has proactively addressed. The company recently published positive results from clinical studies in the Journal of Allergy and Clinical Immunology, further validating neffy's safety and efficacy.

Financially, ARS Pharma is solidly positioned, with an expected $195 million in cash and equivalents by the anticipated neffy launch date. This ensures the company's capability to sustain operations and support the product's market introduction and growth. Additionally, ARS Pharma has expanded its reach by entering into an exclusive distribution agreement with CSL Seqirus for the Australian and New Zealand markets, exemplifying its strategic approach to global commercialization.

The company's latest achievements include the successful completion of a Phase 2 trial for neffy in treating chronic spontaneous urticaria, showing promising results in alleviating symptoms such as itch and hives. ARS Pharma plans to initiate further outpatient studies in 2024, potentially leading to a pivotal efficacy study in 2025.

Overall, ARS Pharmaceuticals stands out for its innovative approach to addressing unmet needs in allergy treatment, demonstrating resilience and commitment to bringing a transformative, needle-free epinephrine solution to patients worldwide.

Rhea-AI Summary

ARS Pharmaceuticals announced that the Committee for Medicinal Products for Human Use (CHMP) recommended the approval of EURneffy (adrenaline nasal spray) for emergency treatment of allergic reactions, including anaphylaxis, in the European Union. This decision marks EURneffy as potentially the first and only needle-free adrenaline option in Europe. The positive opinion is based on extensive data, including studies involving over 700 participants and 1,200 administrations, demonstrating its efficacy and safety. The European Commission is expected to grant formal marketing authorization in Q3 2024, with availability anticipated in Q4 2024. The U.S. FDA is reviewing the same data, with a decision expected by October 2, 2024.

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ARS Pharmaceuticals reported progress in regulatory processes for neffy, an epinephrine nasal spray, with an anticipated FDA review completion by October 2024. The company submitted responses for NDA and MAA to FDA and EMA respectively. ARS is well-capitalized with $223.6 million in cash and securities as of March 31, 2024, supporting neffy's expected U.S. launch in the second half of 2024. Clinical expansion for urticaria is underway, along with partnerships for global commercialization. Financially, R&D expenses decreased, G&A expenses decreased, and the net loss reduced compared to the same quarter in 2023.

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ARS Pharmaceuticals submitted the Day 180 response for neffy (epinephrine nasal spray) Marketing Authorization Application to EMA's CHMP and entered a license agreement with CSL Seqirus for commercialization in Australia and New Zealand. The CHMP opinion on neffy is expected in the second quarter of 2024, addressing all identified issues and including results from a repeat dose study and updated nitrosamine testing. CSL Seqirus will handle regulatory approval, reimbursement, and commercialization, while ARS Pharma will manage manufacturing and supply.

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ARS Pharmaceuticals, Inc. (Nasdaq: SPRY) submits response to FDA CRL for neffy nasal spray, including positive data from repeat dose study and updated nitrosamine testing. The company aims to address FDA concerns and bring neffy to market for patients at risk of anaphylaxis.
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ARS Pharmaceuticals, Inc. (Nasdaq: SPRY) is progressing towards submitting a response to the FDA's Complete Response Letter (CRL) for neffy® nasal spray for Type I allergic reactions, with successful Phase 2 trials and a well-capitalized position. The company aims for an anticipated FDA approval in the second half of 2024.
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ARS Pharmaceuticals, Inc. highlights neffy nasal spray for severe allergic reactions, addressing significant unmet needs in the epinephrine market. The potential best-in-class profile of neffy aims to improve patient compliance and ease of use, offering rapid effects within minutes and eliminating needle-related risks. The company expects FDA approval in the second half of 2024, with plans for significant market expansion. Positive clinical data for urticaria treatment further enhances neffy's potential.
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ARS Pharmaceuticals, Inc. (Nasdaq: SPRY) announces participation in the Leerink Partners Global Biopharma Conference 2024. Company executives to join fireside chat and one-on-one meetings with investors. Webcast available for 90 days.
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ARS Pharmaceuticals, Inc. (NASDAQ: SPRY) announces positive efficacy results for neffy in treating chronic spontaneous urticaria. The phase 2 study showed statistically significant improvements in itch, hives, and erythema. Neffy demonstrated rapid onset of action, with potential for a pivotal study in 2025.
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ARS Pharmaceuticals, Inc. (NASDAQ: SPRY) will host a virtual investor day to showcase neffy® (epinephrine nasal spray) on March 7, 2024. The event features presentations by ARS management and renowned allergists, with a live Q&A session. The webcast can be accessed on the company's website, with a replay available for 90 days.
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ARS Pharmaceuticals, Inc. (NASDAQ: SPRY) announces positive topline results from a study comparing repeat doses of neffy (epinephrine nasal spray) to epinephrine injection under nasal allergen challenge conditions. The study aims to address FDA's concerns highlighted in a Complete Response Letter (CRL) and supports neffy's potential approval for Type I allergies, including anaphylaxis. The company plans to submit a response to the CRL in early Q2 2024, following a six-month review period.
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FAQ

What is ARS Pharmaceuticals' primary product?

ARS Pharmaceuticals is developing neffy, a nasal spray formulation of epinephrine for the emergency treatment of Type I allergic reactions including anaphylaxis.

What makes neffy different from traditional epinephrine autoinjectors?

Neffy is a needle-free nasal spray that addresses issues like needle phobia, portability, and ease of use, aiming for rapid and effective epinephrine absorption.

What are the recent achievements of ARS Pharmaceuticals?

Recent achievements include the completion of clinical studies validating neffy's safety and efficacy, and entering an exclusive distribution agreement with CSL Seqirus for Australia and New Zealand.

When is the expected market launch for neffy?

If approved, the U.S. market launch for neffy is anticipated in the second half of 2024.

How financially stable is ARS Pharmaceuticals?

ARS Pharmaceuticals is well-capitalized, with an expected $195 million in cash and equivalents by the time of neffy's anticipated launch in the second half of 2024.

What regulatory challenges has ARS Pharmaceuticals faced?

ARS Pharma addressed the FDA's additional requirement for a pre-approval repeat-dose rhinitis study, which delayed the initial approval timeline but reaffirmed the company's commitment to meeting regulatory standards.

What are the potential markets for neffy?

In addition to potential approval in the U.S., ARS Pharma is pursuing approval in the European Union and has partnered with CSL Seqirus for commercialization in Australia and New Zealand.

What is the latest clinical trial news for neffy?

Neffy showed positive results in a Phase 2 trial for chronic spontaneous urticaria, meeting primary endpoints and demonstrating rapid symptom control.

Who are ARS Pharmaceuticals' key partners?

One of ARS Pharma's key partners is CSL Seqirus, which will handle the regulatory approval and commercialization of neffy in Australia and New Zealand.

What future studies are planned for neffy?

ARS Pharma plans to initiate further outpatient studies for neffy in 2024, potentially followed by a pivotal efficacy study for chronic spontaneous urticaria in 2025.

ARS Pharmaceuticals, Inc.

Nasdaq:SPRY

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1.02B
96.90M
23.47%
62.23%
7.07%
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